# A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy

> **NCT04027309** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Stichting Hemato-Oncologie voor Volwassenen Nederland** · enrollment: 777 (actual)

## Conditions studied

- Acute Myeloid Leukemia
- Myelodysplastic Syndrome With Excess Blasts-2

## Interventions

- **DRUG:** Gilteritinib
- **DRUG:** Midostaurin

## Key facts

- **NCT ID:** NCT04027309
- **Lead sponsor:** Stichting Hemato-Oncologie voor Volwassenen Nederland
- **Sponsor class:** OTHER
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2019-12-20
- **Primary completion:** 2025-10
- **Final completion:** 2033-06
- **Target enrollment:** 777 (ACTUAL)
- **Last updated:** 2024-12-17

## Collaborators

- [object Object]
- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04027309

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04027309, "A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT04027309. Licensed CC0.

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